Tag Archives: Latin America

INVIMA+ANMAT: inter-agency collaboration activities

During the last Summit of Regulatory Authorities of Regional Reference that took place in Acapulco, Mexico, on the 10th to 21st of February, the representatives of Colombia’s INVIMA and Argentina’s ANMAT, Dr. Blanca Elvira Cajigas de Acosta and Dr. Carlos A. Chiale, … Continue reading

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Americas Health Authorities Meeting

On the 20th and 21st of February of 2014, representatives of the five Latin-American Health Authorities of Regional Reference recognized by the Pan American Health Organization, plus those of the FDA, Health Canada, and El Salvador’s regulatory agency met in … Continue reading

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Mexico at the vanguard with new combination drug

In the past days, COFEPRIS granted approval for the combination drug containing fluticasone furoate and vilanterol, indicated for treatment of chronic obstructive pulmonary disease (COPD) and asthma. Although the product had already been approved in the US by the FDA in … Continue reading

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Argentina: Site Master File now required by ANMAT for national sites

Starting on November 19th, 2o13, sites in Argentina approved by ANMAT to manufacture or package, in own or contract facility, or import or export, both drug products and APIs, have to submit their Site Master Files (SMF) annually. This is … Continue reading

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Brazil: ANVISA bans Lorcaserin (Belviq)

Today ANVISA, the Brazilian health authority with competence on the control of pharmaceutical products and APIs, banned the manufacturing, import, commercialization, manipulation and use of the API Lorcaserin. Lorcaserin is the drug substance of Belviq, an innovative weight-loss product that … Continue reading

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Brazil: Overview of API registration

In Brazil, the health authority (ANVISA) will require that all Active Pharmaceutical Ingredients (APIs) manufactured in Brazil, imported for manufacturing of drug products, or included in imported finished products, are registered with the agency. This regulation has been put in … Continue reading

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Mexico: new guidelines for the acceptance of GMP certificates

In October 2013, the Mexican health authority released a new document setting the criteria that will be used to accept GMP certificates as valid. This criteria applies to certificates of manufacturing facilities both of finished products and API. Summary of … Continue reading

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